Surgical sheath, staple, and scaffold bone anchor devices

ABSTRACT

A surgical bone sheath staple device, anchor, and/or scaffold enables low impact installation of distal end members in bones to secure soft tissue and the like via a deployment system. The bone sheath staples, anchors, and scaffolds secure soft tissue to bone to ensure tailored fixation of soft tissue to bone. The bone staples, anchors, and scaffolds integrate sheath and suture tightening members to secure soft tissue to bone and tailor compression of soft tissue to bone to encourage healing. The bone staples, anchors, and scaffolds integrate sheaths and suture to define attachment mechanisms and other features that secure the staples, anchors, and/or scaffolds to bone.

BACKGROUND 1. Field of the Invention

The present invention relates generally to surgical bone sheath stabledevices, bone sheath anchors, scaffolds integrating sheath anchors, andmethods of use, and more specifically, to a staple sheath anchor thatdirectly or indirectly affixes soft tissue (e.g. tendons, ligaments,etc.) to bone. Embodiments of the invention involve bone sheath staplesthat directly secure and compress soft tissue to bone. Embodiments ofthe invention also involve bone sheath anchors that integrate a suturewith a sheath such that tension is applied to the suture to shape thesheath in an expanded orientation to engage a bone channel and lock thesheath suture anchor to bone. The anchors can then be used to securesoft tissue into engagement with bone. Embodiments of the inventionfurther facilitate placement of scaffolds to bone by integrating orcoupling sheath anchors into the scaffold. The sheath staples, anchorsand/or scaffolds may incorporate a suture or features that pass sutureto augment the affixation of soft tissues to bone. The sheath anchorscan be used in either open or arthroscopic procedures. The sheathanchors are available in different sizes, which allow the attachment ofsoft tissues to bones of different sizes and for different applications.

2. Description of Related Art

One need in orthopedic surgery is the secure attachment of soft tissuesto bones. Bone anchors are commonly used to secure suture to bones wherethe suture can be passed through soft tissue such that when suture knotsare tightened the soft tissue in positioned into engagement against thebone surface.

Providing a bone staple that directly engages soft tissue against boneto secure and compress the soft tissue into engagement against boneaddresses key requirements for soft tissue fixation. Providing a bonesheath staple designed with at least one suture and at least one sheathavoids metal anchors and provides secure attachment and tailoredcompression to encourage healing of the soft tissue to bone. Stabilityis also provided between soft tissue and bone to ensure proper alignmentduring the healing process.

Bone sheath anchors that secure suture to bone so the suture canalternatively be used to engage soft tissue and secure the soft tissueto bone also benefits from an integrated suture and sheath anchordesign. Providing a quick and atraumatic bone sheath anchor that securessuture to bone enables more stable attachment of soft tissue by creatingdouble row, lateral row, or other types of soft tissue attachment.Alternatively, scaffolds may be integrated or coupled with bone sheathanchors or staples to facilitate secure attachment of the scaffolds tobone. These scaffolds, as well as the integrated or coupled anchorcomponents, may be fabricated from biologically inert materials,bioabsorbable materials, nanofibers, or incorporate drugs, biologics,stem cells, other autologous or donor tissues, or other syntheticmaterials designed to enhance healing of soft tissue to boneattachments, improve stability of soft tissue to bone attachments,increase the integrity or performance of soft tissue, or othermedically-indicated reason.

BRIEF SUMMARY OF THE INVENTION

The field of minimally invasive arthroscopic surgical techniques hasrapidly progressed over the last decade and continues to evolve with newtechniques and procedures performed through minimally invasivetechniques. Rotator cuff surgery represents one of the most commonorthopedic surgeries performed. A simple description of this surgeryinvolves identifying the tear, debriding the bone and then securing thetorn tendon to the bone providing greater tuberosity. This is almostuniversally done with the use of suture anchors. The anchor is typicallya screw that may be screwed within a pilot hole or impacted into thebone.

Extending out of the anchor are sutures that are individually passedthrough the tissue and then tied down to secure the tendon to bone. Thisprocess can be complex depending on training, experience and tearpattern. In addition, it can be a time-consuming process passing suturesindividually and tying them to secure soft tissue against bone. Multipleneedle passages can be traumatic to already torn and degenerated tissue.Proper tension/compression is not always achievable with sutures. Thereis also the issue of “knot security”. Knots can become undone or loose.

The objectives of the device provide a staple device or anchorfabricated from at least one suture and at least one sheath. Through thedevices, a skilled surgeon can quickly and efficiently secure therotator cuff to the bone in a one to two step process. A suture will bepassed through the tendon and then through the device for properpositioning and tension. Once appropriate, the tendon is secured to bonethrough the use of a sheath staple that is impacted through the tendonand into bone. The sheath staple will be small enough to limit excessbone and tissue loss and trauma but large enough to provide enoughstrength and compression. The sheath staple may include features toincrease further pull-out tensile force or attachment strength. A sheathanchor may alternatively be used to secure suture to bone so the suturecan subsequently be passed through soft tissue so suture knots can betied to attach the soft tissue to bone. The sheath staple, sheath anchorand/or sheath anchor integrated scaffold devices may be made of polymersheath material, fiberwire, braided, woven or other geometry of sutureor biological textile material, bioabsorbable polymers and/or otherbiocompatible material with appropriate mechanical properties, or acomposite of such materials.

The sheath staple and/or suture anchor may also be integrated toscaffolds that are infused, embedded, or otherwise incorporate collagen,stem cells, drugs, biologics, other autologous or donor tissue, othermedicinal substances, or other material to encourage healing and/orreduce stress on the soft tissue. This technology can be applied to allareas of surgery that use suture anchors to secure tissue to bone e.g.,labral repairs, ligament repairs and reconstruction. This will greatlydecrease surgical time and improve ease of use. It may also lead toincreased rates of healing.

The various embodiments of the present invention provide a variety ofintegrated bone staple devices that affix soft tissue to bone, applytailored compression between soft tissues and bone, or better enablereinforced attachment of soft tissue to bone such as double row orlateral row fixation.

The various embodiments incorporate bone sheath staple implants, sheathanchors, scaffolds that integrate or couple at least one sheath stapleor anchor, deployment systems that inserts the implants, and sheathstaple and/or anchor features that better atraumatically affix softtissue to bone at the insertion sites.

DESCRIPTION OF THE DRAWINGS

The novel features believed characteristic of the embodiments of thepresent application are set forth in the appended claims. However, theembodiments themselves, as well as a preferred mode of use, and furtherobjectives and advantages thereof, will best be understood by referenceto the following detailed description when read in conjunction with theaccompanying drawings, wherein:

FIG. 1 shows a side view of a bone sheath staple embodiment thatincorporates a suture tightening member that actuates the distal endmembers of the sheath within bone channels to directly secure softtissue to bone.

FIGS. 2A to 2C show a side view, a perspective view, and an end view ofa deployment system for the bone sheath staple embodiment of FIG. 1.

FIGS. 3A to 3E show side-sectional views of two bone sheath stapleembodiments that incorporate at least one suture tightening member thatactuates the distal end members of the sheath within the bone channelsto secure the sheath staple to bone.

FIGS. 4A to 4H show side-sectional views of four bone sheath anchorembodiments with differing suture tightening member configurations thatcause the at least one distal end member of the sheath to deform, expandand/or otherwise engage the at least one bone channel to secure thesheath anchor to bone.

FIGS. 5A to 5B show a top-sectional view and a side-sectional view of anelongated ribbon sheath scaffold embodiment that integrates bone sheathanchors by incorporating at least one suture tightening member coupledto at least one end of the scaffold that facilitates attachment of atleast one distal end member of the scaffold within at least one bonechannel.

FIGS. 6A to 6C show side-sectional views of three elongated sheathscaffold embodiments that integrate bone sheath anchors by incorporatingat least one suture tightening member to at least one distal end memberof the scaffold to facilitate attachment of at least one end of thescaffold within at least one bone channel.

FIG. 7A shows an end view of a scaffold embodiment that incorporatesmultiple individual scaffold support members, each attached to bone withintegrated sheath anchors.

FIGS. 7B to 7D show end views of three scaffold embodiments thatintegrate mesh or other textile support sheets with sheath supportmembers that integrate sheath anchors to facilitate attachment of thescaffolds to bone.

FIGS. 8A to 8B show top views of a sheet scaffold that incorporatesindividual sheath anchors that attachment the scaffold to bone.

FIG. 9 shows a side sectional view of a scaffold embodiment attached tobone by actuation of sheath anchors incorporated or coupled to thescaffold.

FIGS. 10A to 10B show a side view and an end view of a deployment systemin an open orientation to place a bone sheath staple, which may also bemodified to insert a sheath anchor or sheath scaffold anchor, to preparefor insertion of the distal end members of the sheath staple or anchor,into a bone channel to secure the staple, anchor, or scaffold to bone.

FIGS. 11A to 11B show the system in FIGS. 10A to 10B in a closedposition that is prepared to deploy the staple, anchor, or scaffold intoa bone channel by tapping to create a bone channel and simultaneouslyinserting the distal end members of the sheath staple or anchor.

While the system and method of use of the present application issusceptible to various modifications and alternative forms, specificembodiments thereof have been shown by way of example in the drawingsand are herein described in detail. It should be understood, however,that the description herein of specific embodiments is not intended tolimit the invention to the particular embodiment disclosed, but on thecontrary, the intention is to cover all modifications, equivalents, andalternatives falling within the spirit and scope of the presentapplication as defined by the appended claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Illustrative embodiments of the system and method of use of the presentapplication are provided below. It will of course be appreciated that inthe development of any actual embodiment, numerousimplementation-specific decisions will be made to achieve thedeveloper's specific goals, such as compliance with system-related andbusiness-related constraints, which will vary from one implementation toanother. Moreover, it will be appreciated that such a development effortmight be complex and time-consuming, but would nevertheless be a routineundertaking for those of ordinary skill in the art having the benefit ofthis disclosure.

The system and method of use in accordance with the present applicationovercomes one or more of the above-discussed problems commonlyassociated with conventional bone staple and anchors. Specifically, theinvention of the present application provides a non-invasive andefficient method of joining ruptured or damaged soft tissue to bone tofacilitate their healing. This and other unique features of the systemand methods of use are discussed below and illustrated in theaccompanying drawings.

The system and method of use will be understood, both as to itsstructure and operation, from the accompanying drawings, taken inconjunction with the accompanying description. Several embodiments ofthe system are presented herein. It should be understood that variouscomponents, parts, and features of the different embodiments may becombined together and/or interchanged with one another, all of which arewithin the scope of the present application, even though not allvariations and particular embodiments are shown in the drawings. Itshould also be understood that the mixing and matching of features,elements, and/or functions between various embodiments is expresslycontemplated herein so that one of ordinary skill in the art wouldappreciate from this disclosure that the features, elements, and/orfunctions of one embodiment may be incorporated into another embodimentas appropriate, unless described otherwise.

The preferred embodiment herein described is not intended to beexhaustive or to limit the invention to the precise form disclosed. Itis chosen and described to explain the principles of the invention andits application and practical use to enable others skilled in the art tofollow its teachings.

The bone staple and anchor embodiments included in this applicationpresent improvements to increase functionality and clinical utility forembodiments in pending patent application Ser. No. 15/973,303 entitled“Surgical bone staple device and method of use” and Ser. No. 17/332,612entitled “Surgical bone stable device and method of use”, the contentsof these documents are hereby incorporated by reference as if recited infull herein.

Referring now to the drawings wherein like reference characters identifycorresponding or similar elements throughout the several views, FIGS.1-11 depict several embodiments of the invention of the application. Itshould be understood that the embodiments discussed herein aresubstantially similar in form and function and share one or more of thefeatures discussed in each embodiment although the features may not beshown specifically with reference to the particular embodiment.

FIGS. 1-2 depict a bone sheath staple device 10 embodiment exemplifiedby this disclosure. The bone sheath staple 10 directly secures softtissues to bone without using individual suture anchors, allowing asurgeon to institute placement of a fastener to retain the soft tissueon an underlying bone with minimal damage to the soft tissue or thebone. Several embodiments of the bone sheath staple device are containedwithin this disclosure.

The bone sheath staple device 10 includes two or more parallel legs 80that include distal end members 40 that are actuated into a deformed,expanded, or otherwise secure orientation upon penetration through softtissue and into bone channels during insertion of the bone sheathstaple. The legs 80 include the distal end members 40 that are actuatedby retraction of at least one integrated suture tightening member 30 tosecure the distal end members 40 into bone channels to increase pull-outforce and better ensure tensile strength of the secured soft tissue tobone attachment.

The embodiments of the invention incorporate at least one sheath 20 madeof polymer strands braided, woven, or otherwise fabricated into atubular mesh or other elongated geometry that incorporates the parallellegs 80 and the distal end members 40 that may be tapped into a bonechannel such that actuation of suture tightening member 30, which iscoupled to the sheath 20 and passes through side wall puncture sites 70to cause actuation of the parallel distal end members 40 to deform,expand, or otherwise engaged within the bone channel to secure to thesheath staple, thus the encapsulated tendon, to bone thereby ensuringattachment between the sheath staple, tendon, and bone.

As FIG. 1 shows, the bone staple device 10 in some embodiments combinesa single suture tightening member 30 and a single sheath 20 to securetendon or other soft tissue directly to bone. A single sheath 20 ofpolymer strands woven or otherwise fabricated into a mesh, braid, orother tubular, ribbon, or alternative elongated geometry has ends thatare heat treated, glued, molded, or otherwise stabilized to avoidunraveling of the sheath 20 during or after deployment.

A single suture tightening member 30 in some embodiments, consists of a2-0 fiber-wire, polyester, PTFE, or other strong suture material is fedthrough the sheath 20 such that the middle portion resides within thebase 50 of the sheath while the opposite ends pass through side wallpuncture sites 70 of the sheath 20 to define and/or actuate distal endmembers 40 of the sheath 20. The suture tightening member 30 is fed backthrough the side wall puncture sites 70 of the sheath 20 while exitingjust before the base 50 of the bone sheath staple. The free ends of thesuture tightening member 30 may be pre-tied into a knot such that onceinserted, retraction of one or more free ends of the suture tighteningmember 30 causes the distal end members 40 to deform, expand indiameter, or otherwise engage the bone channel through which the distalend members 40 of the bone sheath staple 10 were tapped. Once fullengagement of the distal end members 40 of the bone sheath staple 10within the bone channel has been obtained, the pre-tied knot maintainsthe bone sheath staple in the attached orientation and the free ends ofthe suture tightening member 30 may be used to tie to other bone sheathstaples or anchors to affect a double row anchor, a lateral row anchor,or may otherwise be passed through other tendons, ligaments, and/ormuscle to affix those soft tissues to the bone sheath staple.

FIG. 3A shows the bone sheath staple 10 embodiment of FIG. 1 in anon-deployed orientation. FIG. 3B shows the bone sheath staple 10 ofFIGS. 1 and 3A in an actuated orientation where the distal end members40 have been inserted through tendon or other soft tissue 210 and into achannel through bone 200. Once inserted into bone channels, the distalend members 40 are actuated by retraction of the free ends of the suturetightening member 30 to deform, expand, or otherwise engage the distalend members 40 within the bone channel. The free ends of the suturetightening member 30 are tied into a knot 90 to maintain the actuatedorientation of the distal end members 40.

FIG. 3C shows an alternative bone sheath staple 10 embodiment where thesuture tightening member 30 is passed through the sheath ends 60 beforepassing through the side wall puncture sites 70. FIG. 3D shows the bonesheath staple 10 of FIG. 3C in an actuated orientation. FIG. 3E showsthe actuated bone sheath staple 10 of FIG. 3D with tendon or other softtissue 210 compressed against bone 200 after the distal end members 40are secured within the bone channels.

It should be noted that the free ends of the sheath staple mayalternatively be secured to the sides of the sheath legs 80 at thelocations where the suture strands pass back into the legs 50 of thesheath 20 past the distal end members 40 and before they exit the base50 from where they can be tied. It should also be noted that more thanone suture tightening member 40 may be incorporated in the sheath 20 toenhance deformation, enlargement, or otherwise engagement of at leastone distal end member 40 within at least one bone channel or in thepresented embodiment, parallel distal end members 40 within two parallelbone channels.

FIG. 2A to 2C show a deployment system 100 that is used to tap thedistal end members 40 of the bone sheath staple 10 into bone by creatingbone channels and inserting the distal end members 40. The deploymentsystem 100 creates parallel bone channels into which the distal endregions 40 can be inserted and activated by tightening of the bonesheath staple suture member 30 to secure the staple to the bone. Priorto tapping the bone sheath staple into bone, the deployment system 100is used to pass the distal end members 40 of the bone sheath staple 10through tendon or other soft tissue.

Once the deployment system 100 is used to create a bone channel whilesimultaneously inserting the distal end members 40 of the sheath staple10 into the tapped bone channels, the suture tightening member 30 freeends are retracted causing the distal end members 40 to deform, expand,or otherwise engage the bone channel thereby securing the bone sheathstaple 10 to the bone. This deployment process simultaneously securesthe bone sheath staple 10 to bone and compresses the tendon or othersoft tissue 210 between the base 50 of the bone sheath staple and bone200.

It should be noted that pre-drilled bone channels may be created tofacilitate insertion of the distal end members 40 into the bone channelsprior to actuation of the at least one suture tightening member 30 whichdeforms, expand, or otherwise engages distal end members 40 within thebone channels.

It should be noted that a one way valve involving a stiff polymer withfeatures that allow the ends of the suture tightening member 30 to passonly one way may be used in lieu of pre-tied knot to secure the suturein the retracted, tightened orientation thus maintaining the bone sheathstaple in the actuated/attached orientation.

The deployment system 100, as shown in FIG. 2A to 2C, includes an activehousing 120 with two parallel supports 110 that each incorporates twopenetrating needles 150 that include sharp ends 130 capable ofpenetrating bone to create the bone channel. The penetrating needles 150support the distal end regions 40 of the sheath staple 10 duringinsertion into bone channels. Each set of penetrating needles 150includes a distal slot 140 between the sharp ends 130 for the distal endregions 40 of the bone sheath staple 10 to reside while insertingthrough the bone channel. The sharp ends 130 of the penetrating needles150 define cutting or dilating features so as to create a channel intobone while the operator applies impact force against the deploymentsystem base 120 to tap the bone sheath staple 10 distal end members 40into channels created in bone by the penetrating needles 150. Each setof penetrating needles 150 may be fabricated from separate componentsthat are connected together or a single needle that includes a centralcut-out 140 within which the distal end regions 40 of the bone sheathstaple 10 resides during deployment.

The deployment system may include a stabilizing bar to support the base50 of the bone sheath staple, thus the captured tendon or other softtissue, during deployment. Once the deployment system taps thepenetrating needles 150 into bone, creating two parallel bone channelswithin which the distal end members 40 of the sheath 20 aresimultaneously inserted, the penetrating needles 150 are retracted whilethe free ends of the suture tightening member 30 are used to actuate thedistal end members 40 while the stabilizing bar maintains theorientation of the base 50 to ensure the bone sheath staple 10 does notmove while the suture tightening member 30 is actuated to secure thedistal end members within the bone channels.

FIGS. 10A and 10B show an alternative deployment system 100 thatincludes a loading orientation to insert the bone sheath staple 10 priorto deployment. Once the bone sheath staple 10 is positioned between thepenetrating needles 150 of the parallel supports 110 and abuts thestabilizing base at the cut-out slots 140, the parallel supports 110 andassociated penetrating needles 150 of the deployment system 100 areclosed for deployment as shown in FIGS. 11A and 11B.

It should be noted that the deployment system 100 embodiments above mayalternatively incorporate a single support 110 coupled to the housing120 that includes the penetrating needles 150. In this alternativeembodiment, the deployment system with a single set of penetratingneedles 150 is configured to insert a single distal end member 45 of abone sheath anchor 15 into a bone channel as will be discussed below.

FIG. 4A shows a bone sheath anchor 15 embodiment of the invention thatconsists of a single sheath 25 with a single suture tightening member 35that passes through the side wall puncture sites 75 on opposite sheathlegs 85 to define a single distal end member 45 that deforms, expand, orotherwise engages a bone channel upon tightening of the suture member 35free ends and tying into a knot 95 as shown in FIG. 4B.

FIGS. 4C and 4D show non-deployed and actuated orientations for analternative bone sheath anchor 15 embodiment of the invention. This bonesheath anchor 15 embodiment passes the suture tightening member 35through the sheath ends 65 and inward through side wall puncture sites75 and back through the lumen of the sheath along the distal end member45 to define a different actuation orientation as shown in FIG. 4D.

FIGS. 4E and 4F show non-deployed and actuated orientations for anotherbone sheath anchor embodiment 15 where the suture tightening member 35passes outward through the side wall puncture sites 75 so the sheathbunches upon tightening of the free suture member 35 ends.

FIGS. 4G and 4H show non-deployed and actuated orientations for anotherbone sheath anchor embodiment 15 where one sheath end 65 is insertedthrough the side wall of the sheath 25 and abuts the other sheath end65. The suture tightening member 35 is wound around the loop defined bythe sheath after passing through the side wall puncture sites 75 and thefree ends of the suture tightening member 35 pass through the sheathends 65.

FIG. 5A shows a scaffold 17 fabricated from a ribbon with paralleltubular sheath members 27 capable of defining a structure to whichtendon or other soft tissue can better heal to bone 200. Suturetightening members 37 are positioned at each end of the scaffold throughthe sheath ends 67 and side wall puncture sites 77 to loop through thesheath members 27 and define distal end members 47 thus scaffold anchorsthat can be actuated upon insertion of the distal end members 47 intobone channels and actuation of the suture tightening members 37 as shownin FIG. 5B.

FIGS. 6A to 6C show three alternative sheath scaffold 18 embodimentsthat integrate sheath anchors into the sheath 28. The sheath scaffold 18embodiment in FIG. 6A includes suture tightening members 38 that definedistal end members 48 by passing through the sheath ends 68 and loopingthrough the side wall puncture sites 78. Once the distal end members 48are inserted into bone channels and the suture tightening member 38 isactuated, the distal end members 48 are secured within the bone channelto secure the sheath scaffold 18 in place as shown in FIG. 9.

The sheaths 28 of the scaffold embodiments may incorporate complexgeometries where the tubular ends are flattened between the integratedsheath scaffold anchors to define anchor regions and bone scaffoldregions.

FIG. 6B shown an alternative sheath scaffold 18 embodiment where twosuture tightening members 38 pass through the entire length of thesheath 28 and pass through side wall puncture sites 78 to define thedistal end members.

FIG. 6C shows an alternative sheath scaffold 18 embodiment where thesuture tightening members 38 are passed through side wall puncture sites78 and wound into a complex orientation within the sheath lumen toenhance the deformation, expansion, or otherwise engagement of thedistal end members within bone channels.

The sheath scaffolds 18 above may be secured to bone in variousconfigurations including the crossing pattern shown in FIG. 7A.Alternative patterns may alternatively be created to provide a scaffoldto which tendon or other soft tissue can be secured to promote stabilityand healing to bone 220.

The individual scaffold sheaths 28 may support a mesh or sheet members22 that can be secured to bone 220 by insertion and attachment of thescaffold anchors into bone channels as shown in FIG. 7B. Alternativescaffold configurations with scaffold sheaths 28 that support mesh orsheet members 22 are shown in FIGS. 7C and 7D.

FIGS. 8A and 8B show alternative scaffold embodiments that incorporatesheath anchors 15 as described previously. The sheath anchors 15 aretapped into bone and secured within the bone channels to secure the meshor sheet member 22 to bone 220. The free ends of the suture tighteningmembers 35 may be subsequently tied into knots 95 to further reinforceposition of the scaffold against bone and to facilitate attachment oftendon or other soft tissue to the scaffold and bone.

The bone sheath staple devices, anchors, and scaffolds shown are merelyrepresentative of several variations and embodiments of the invention.It is not the intent to limit the scope of the staples, anchors,scaffolds, and instruments used to insert the staples or anchors intobone channels, nor to limit the use of the staples, anchors, orscaffolds to rotator cuff repairs. It is ideal for rotator cuff repairs,but surgeons may choose to use the staples for other soft tissue andother bone attachments.

The sheath staples are also not limited to two prong embodiments and mayutilize one staple leg or a plurality of staple legs, with or withoutsheaths or other features, and in configurations not necessarily linear,including a triangular configuration, a square configuration or apolygon, with more than one bridge between the staple distal end membersor in a geometrical design suitable for the tissue repairs.

The staples, anchors, and scaffolds may be deployed by otherapparatuses, although a hard contact implement is not recommended due tothe risk of penetration of the soft tissue, deformity or damage to thesoft tissue or bone. The staples, anchors, and scaffolds may be made ofmetal, thermoplastic, nitinol, suture material, silicone, urethane,PTFE, nylon, other polymer, other biocompatible and bioabsorbablematerial, or a combination of materials use in implant devices. Inaddition, coverings may be placed over sections of the bone staples,anchors, and scaffolds to reduce stresses on soft tissue, furtherencourage healing, or other purpose that enhances the secure attachmentof soft tissue to bone. Although the embodiments of the have beendescribed and shown above, it will be appreciated by those skilled inthe art that numerous modifications may be made therein withoutdeparting from the scope of the invention as herein described.

While various orthopedic applications benefit from the use of bonestaple anchor embodiments of the invention, rotator cuff tendon repair(e.g. partial or complete tears) is one illustrative example that willbe described in more detail. The rotator cuff tendon tear is identifiedand the tendon is debrided. The tuberosity insertion site is likelydecorticated. The tendon is approximated to its insertion site. Throughpercutaneous techniques, arthroscopic cannulas or open approaches thetendon is secured down to the footprint by insertion of the bone sheathstaple device into the tendon and then into the bone.

Proper distal end member deployment and resistance to pullout isconfirmed by pulling on the device the inserter or sutures that runthrough it. This device may be used with or without sutures. Suturetightening members are integrated within the staple, anchor, and/orscaffolds as shown in the embodiments above. The bone sheath staples,anchors, and/or scaffolds may then be used to create a double rowconstruct by placing lateral to the initial staple or anchor. It mayalso be placed medial or lateral to the initial staple or anchor. Itshould be noted that any number of bone sheath staples, anchors, and/orscaffolds may be utilized to ensure proper placement and attachment ofsoft tissue to bone.

Other applications that benefit from the bone sheath staple, anchor,and/or scaffold embodiments of the invention include biceps tenodesiswhere the short head or long head of the biceps tendon is secured to thegroove, total shoulder arthroplasty where the subscapularis tendon isrepaired, attaching grafts when performing procedures such as superiorcapsular reconstruction, securing grafts to the glenoid, fixing theanterior cruciate ligament, repairing the medial and/or lateralcollateral knee ligaments or any application requiring the attachment ofsoft tissue to bone.

The staple, anchor, and/or scaffold embodiments of the invention mayalternatively include securing triceps tendon, achilles tendon, patellatendon, or quadriceps tendon to bone. The embodiments of the inventionmay also help support ligaments including ankle ligaments (e.g deltoidligament), knee ligaments (e.g anterior cruciate ligament), elbowligaments (e.g ulnar collateral ligament), shoulder ligament (e.gglenohumeral ligament), hip ligaments, and ligaments of the hand andwrist. The embodiments may be used in conjunction with elective ornon-elective procedures for lateral collateral ligament repair in elbowinstability surgery. The embodiments may be used to aid fracture repairby providing provisional fixation across the fracture fragments. Theembodiments may be used to facilitate fixation of biologic augments andgrafts including autograft tendons used for healing, cadaveric tendonsallograft used to facilitate healing, cadaveric tendon allograft used toincrease structural support, autograft tendon used to facilitatehealing, human dermal allografts, all grafts used in superior capsularreconstructions of the shoulder, and augmenting soft tissue repair withsynthetic, cadaveric or autologous material.

To achieve the variety of applications, it is possible that theembodiments of the invention may manufactured at different dimensions.In addition, the deployment mechanism may be altered to facilitateaccess and use in different body parts.

The bone sheath staple, anchor and/or scaffold embodiments disclosedabove are illustrative only, as the embodiments may be modified andpracticed in different but equivalent manners apparent to those skilledin the art having the benefit of the teachings herein. It is thereforeevident that the particular embodiments disclosed above may be alteredor modified, and all such variations are considered within the scope andspirit of the application. Accordingly, the protection sought herein isas set forth in the description. Although the present embodiments areshown above, they are not limited to just these embodiments, but areamenable to various changes and modifications without departing from thespirit thereof.

What is claimed is:
 1. A bone sheath staple device, comprising: a sheathhaving: a first leg having a first distal end member; a second leghaving a second distal end member; a suture tightening member engagedwith the first distal end member and the second distal end member;wherein the first leg and the second leg pass through soft tissue priorto insertion into bone; wherein tension applied to the suture tighteningmember retracts the first distal end member and the second distal endmember to increase pull-out force; and wherein the bone sheath stapledevice is configured to secure soft tissue to bone.
 2. The device ofclaim 1, wherein the sheath further includes: a first puncture sitethrough the sheath; wherein the suture tightening member extends throughthe first puncture site.
 3. The device of claim 1, wherein the suturetightening device includes a first end and a second end and wherein eachof the first and second ends are tied to create knots.
 4. A bone sheathstaple system, comprising: a bone sheath staple device, having: a sheathhaving: a first leg having a first distal end member; a second leghaving a second distal end member; a suture tightening member engagedwith the first distal end member and the second distal end member; adeployment system, having: a housing; a first parallel support extendingfrom the housing and to engage with the first leg; and a second parallelsupport extending from the housing and to engage with the second leg;wherein the deployment system is configured to insert the first distalend member and the second distal end member into bone; wherein force tothe suture tightening member retracts the first distal end member andthe second distal end member to increase pull-out force; and wherein thebone sheath staple device is configured to secure soft tissue to bone.5. The system of claim 4, wherein the first parallel support includes apenetrating needle at a distal end of the parallel support.
 6. Asurgical scaffold, comprising: a parallel tubular sheath, having a firsttubular member and a second tubular member; a first suture tighteningmember through a first end of the first tubular member and a first endof the second tubular member; a second suture tightening memberextending through a second end of the first tubular member and a secondend of the second tubular member; wherein actuation of the first suturetightening member actuates the first end of the first tubular member andthe first end of the second tubular member; wherein actuation of thesecond suture tightening member actuates the second end of the firsttubular member and the second end of the second tubular member; andwherein the actuation causes the parallel tubular sheath to engage witha bone channel.